Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-04 @ 8:02 PM
Study NCT ID:
NCT00732394
Status:
UNKNOWN
Last Update Posted:
2008-08-12
First Post:
2008-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-08', 'studyFirstSubmitDate': '2008-08-08', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To document the musculoskeletal profile of patients with low back pain', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To determine if a particular lower back diagnosis or MSDR® score can predict which patients will respond particularly well to the DRX9000™ treatment protocol and spinal manipulative therapy.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.medappraise.com', 'label': 'MSDR'}]}, 'descriptionModule': {'briefSummary': 'To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have Informed Consent Signed\n* Lumbar Disc Herniations under 5mm without Sequestered Fragments\n* Lumbar Disc Bulging\n* Lumbar Degenerative Disc Disease (mild and moderate severity)\n* Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65 years of age\n* Segmental Dysfunction Secondary to Dyskinesia\n* Unresolved Nerve Entrapment Syndrome\n* Patients must be able to comply with study protocol\n* Joint Fixation Syndrome\n* Premenopausal Female Patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-HCG pregnancy test performed within 48 hours before initiating protocol specified treatment.\n\nExclusion Criteria:\n\n* Contraindications to Spinal Manipulative Therapy\n* Lumbar Canal Stenosis resulting in significant neurological comprimise\n* Any Spinal Cord Compression resulting in significant neurological comprimise\n* Cauda Equina Syndrome\n* Infection\n* Osteomyelitis\n\n -\\>65 years of age\n* History of Back or Neck Surgery\n* Acute Arthritis\n* Signs or Symptoms of Arterial Aneurysm\n* History of Active Cancer with Bone Metastasis\n* Widespread Staphyloccal and/or Strepococcal Infection\n* Acute Gout\n* Serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric.\n* Unstable Spondylosis, Spondylolisthesis, or Spondylolysis\n* Prior adverse experience with Spinal Manipulation Therapy\n* Uncontrolled Diabetic Neuropathy\n* Gonorreal Spinal Arthritis\n* Tuberculosis to the Bone\n* Maligancy with Metatasis to Bone\n* Excessive Spinal Osteoporosis\n* Osteomalacia\n* Ankylosis\n* Syphlitic Articular or Peri-Articular Lesions\n* Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury'}, 'identificationModule': {'nctId': 'NCT00732394', 'briefTitle': 'A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedAppraise, Inc.'}, 'officialTitle': 'This is a Study is for the Purpose of Quantifying Function of the Back and Lower Extremities, and to Assess the Inter-Regional Biomechanical Relationships of the Neck, Upper Extremities, Back, and Lower Extremities in Patients Suffering From Chronic Low Back Pain.', 'orgStudyIdInfo': {'id': 'TCT06-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MSDR', 'type': 'OTHER', 'otherNames': ['Musculoskeletal Disorder Reporting Tool'], 'description': "The MSDR® questionnaire establishes an individual's musculoskeletal functional status using information gathered from 1) a questionnaire the patient fills out regarding medical history, chronic medical conditions, and health risk factors; 2) anatomic pain survey completed by the patient; and 3) evaluation by a trained researcher of various patient biometric parameters related to range of motion. Stratifying an individual into a risk category with this evidence-based assessment tool then permits an assessment of which patients respond long term to therapy.\n\nMSDR® demonstrates the ability to benchmark specific musculoskeletal findings (both clinical and sub-clinical) to ICD-9 Diagnoses supported by diagnostic, radiographic and/or MRI findings where clinically indicated."}]}, 'contactsLocationsModule': {'locations': [{'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tammy Cravotta', 'role': 'CONTACT', 'phone': '727-797-0500'}, {'name': 'Matt Erickson, DC', 'role': 'CONTACT', 'phone': '727-797-0500'}], 'facility': 'Back2Life of Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}], 'centralContacts': [{'name': 'Eric K Groteke, DC', 'role': 'CONTACT', 'email': 'egroteke@medappraise.com', 'phone': '727-797-0500'}, {'name': 'Damon J Stafford, DC', 'role': 'CONTACT', 'email': 'drdamon7@aol.com', 'phone': '727-797-0500'}], 'overallOfficials': [{'name': 'Eric K Groteke, DC', 'role': 'STUDY_CHAIR', 'affiliation': 'MedAppraise, Inc.'}, {'name': 'Luis Crespo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Crespo and Associates'}, {'name': 'Mark Scinico, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Concentra'}, {'name': 'Damon J Stafford, DC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Back2Life of Florida, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedAppraise, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Damon J. Stafford, D.C.', 'oldOrganization': 'Back2Life of Florida, Inc.'}}}}